Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
FDA product code CCK · 293 cleared devices
Class 2
Anesthesiology
- Regulation
- 21 CFR 868.1400
- Review panel
- AN
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1977-02-01 – 2026-08-12
CCK
2026-08-12
CCK
2026-07-14
VisuBreath
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CCK
2026-05-01
Capnostream™35 Portable Respiratory Monitor (PM35MN)
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CCK
2025-08-28
Medical Gas Analyzer (AG200)
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CCK
2025-06-10
TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
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CCK
2025-06-04
0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
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CCK
2024-12-16
AIM (N/A)
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CCK
2024-11-12
AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask
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CCK
2024-11-07
MicroTrend System
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CCK
2023-11-21
Oxy2Pro
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CCK
2023-09-12
Endure ETCO2/02 Nasal Cannula
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CCK
2023-04-05
CO2 Mainstream Sensor
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CCK
2023-01-30
XChange Device, XChange System
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CCK
2022-11-16
Endoscopy Oxygen Mask
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CCK
2022-07-29
Microstream CO2 NanoPod
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CCK
2022-04-12
CARESCAPE CO2 Microstream parameter
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CCK
2021-10-21
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories
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CCK
2021-09-17
Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector
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CCK
2021-03-29
EMMA Capnograph
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CCK
2021-03-04
Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+
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CCK
2020-05-22
CO2 Sidestream Module
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CCK
2020-05-21
CO2 Mainstream Module
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CCK
2020-04-27
Capnostream 35 Portable Respiratory Monitor
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CCK
2020-01-17
Altera gas Sampling Lines
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CCK
2019-12-18
Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric
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CCK
2019-05-23
MaxCap Ped and MaxCap Neo
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CCK
2019-05-01
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
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CCK
2019-03-22
Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line
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CCK
2019-02-08
Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line
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CCK
2019-02-06
CO2 Sampling Line
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CCK
2019-01-11
MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly
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CCK
2018-07-18
Capnograph and Oximeter
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CCK
2018-06-20
SuperNO2VA Et Device
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CCK
2018-05-31
ETCO2 Sensor
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CCK
2018-04-30
Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable
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CCK
2018-04-19
Panoramic Oxygen Mask (POM)
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CCK
2018-01-04
OmniCap
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CCK
2017-12-26
IntelliVue Capnography Extension, IntelliVue Microstream Extension
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CCK
2017-10-11
Nihon Kohden CO2 Monitor
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CCK
2017-08-17
CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories
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CCK
2017-03-17
OC-FLEX Flexible IntraOral Cannula
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CCK
2017-02-24
TG-970P CO2 Sensor Kit
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CCK
2016-12-14
Westmed Gas Sampling Cannula with O2 delivery
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CCK
2016-03-10
Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
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CCK
2013-12-31
M1 CAPNOGRAPHY MASK
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CCK
2013-11-25
CAPNOMASK
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CCK
2013-05-21
TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)
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CCK
2013-03-21
CAPNO MODULE, 92517
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CCK
2012-12-20
DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER
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CCK
2012-11-29
MICROSTREAM FILTERLINE ICU
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CCK
2012-10-25
IRMA C02 MODEL 200101; IRMA AX 200601
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CCK
2012-07-19
CAPNOSTREAM20P WITH AI/ODI
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CCK
2012-07-13
CAPNOGRAPHY PAD (92516)
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CCK
2012-07-13
CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR
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CCK
2012-05-04
END TIDAL CO2 NASAL CANNULA
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CCK
2011-10-28
GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS
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CCK
2011-04-06
ISA CO2, ISA AX+, ISA OR+
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CCK
2010-05-12
CAPNOSTREAM20 WITH MICROMEDICO2 MODULE
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CCK
2010-04-23
INFINITY MCABLE - MAINSTREAM CO2
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CCK
2010-03-04
SMART CAPNOLINE GUARDIAN
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CCK
2009-12-10
ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE
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CCK
2009-03-02
NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
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CCK
2009-02-23
NEO-STAT CO2 <KG
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CCK
2008-10-31
TWINGUARD WITH CAPNOGRAPH ACCESSORY
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CCK
2008-09-04
VEO MULTIGAS MONITOR FOR POCKET PC
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CCK
2008-03-26
VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA
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CCK
2007-12-28
EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG)
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CCK
2007-11-29
YG-125T AND YG-135T NASAL ADAPTER
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CCK
2007-08-23
PEDI CO2 EASY
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CCK
2007-02-15
CO2 EASY
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CCK
2007-02-06
EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG)
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CCK
2006-12-27
CARBON DIOXIDE MONITOR, MODEL OLG-2800A
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CCK
2006-02-03
INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A
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CCK
2006-01-12
LOFLO C5 CO2 SENSOR
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CCK
2005-12-13
PRO-FLOW MULTIPURPOSE CANNULA
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CCK
2005-11-02
DATEX-OHMEDA S/5 INTERFACE MODULE E-INT
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CCK
2005-10-14
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES
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CCK
2005-09-15
VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221
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CCK
2005-09-08
DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES
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CCK
2005-03-01
C-CO2 COLORIMETRIC CO2 INDICATOR
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CCK
2004-11-23
SMART BITEBLOC
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CCK
2004-11-19
CAPNOSTAT 5
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CCK
2004-10-15
CAP-ONE, MODEL TG-920P
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CCK
2004-08-09
EMG - ESSENTIAL GAS MODULE, MODEL M1013A
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CCK
2004-06-18
MODIFICATION TO NICO WITH MARS, MODEL 7300
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CCK
2004-06-17
MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR
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CCK
2004-05-13
POLARIS 2004 CAPNOGRAPH
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CCK
2004-02-09
MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
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CCK
2003-10-07
NICO WITH MARS, MODEL 7300
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CCK
2003-08-19
ADVISOR, MODEL 9200
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CCK
2003-08-14
STATCO2METER, MODEL 10-55372
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CCK
2003-07-30
MINI STATCO2 CO2 DETECTOR, MODEL 10-55371
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CCK
2003-05-07
CO2 CLIP
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CCK
2003-04-23
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES
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CCK
2003-01-28
GAS SAMPLING LINES
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CCK
2002-11-04
MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370
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CCK
2002-07-25
MULTIGAS UNIT, MODEL AG-920RA
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CCK
2002-06-11
OXYARM CO2
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CCK
2002-01-17
VAMOS ANESTHETIC GAS MONITOR
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CCK
2001-11-29
MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE
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